Consultant Profiles
Orion Canada’s success is the
result of the industry’s best consultants working
together to deliver significant value to its clients.
When you partner with Orion Canada Inc., you
engage a team of experts. Below are brief profiles of
some of our consultants.
Joe
FitzGibbon, President, Orion Canada Inc. |
Joe
FitzGibbon, President and co-founder of Orion Canada
Inc., has 20+ years of experience as a certified Lead Auditor and ISO
9001, ISO 14001 and ISO 13485 consultant, specializing
in management best practices and regulatory compliance.
Joe has over 25 years as a quality system consultant,
auditor and trainer, and holds the highest certifications
in those fields. He is an accomplished author
on international medical device regulations and
a highly sought after speaker at conferences. Prior
to founding Orion Canada, Joe spent several years
in the Canadian Federal Government,
holding executive level positions in
management, regulatory and consulting
environments. |
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Chris
FitzGibbon, Vice President, Orion Canada
Inc. |
Chris
FitzGibbon has led numerous “break-through” process
improvement projects in mission critical industries
including IT/software, telecom, aerospace,
defense, engineering,
government, manufacturing and service sectors. Chris is an American Society
for Quality (ASQ) Certified Manager of Quality/Organizational
Excellence (CMQ-OE)
and a Certified Software Quality Engineer (CSQE).
Chris has performed 1000+ audits for
registrars and clients, mostly of mission
critical systems and organizations
(aerospace, medical, defense, software, IT,
security, regulatory, etc.). |
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His
auditing credentials include: Certified Information
System Auditor (CISA) by the Information Systems
Audit and Control Association (ISACA), QMS Lead Auditor by the International Registrar of
Certificated Auditors (IRCA), ASQ Certified Quality
Auditor (CQA), Medical Device Lead
Auditor (MDSAP: ISO 13485, FDA, Health
Canada, MDR, UKCA, etc.). Chris also has extensive experience
consulting with standards such as ISO 9001,
ISO 13485, AS9100, ISO 27001 and
others.
He
represented Canada on the ASQ Software Division’s
regional council for seven years. And, Chris was awarded the
prestigious International
Quality Award - Feigenbaum Medal for outstanding
achievement and recognition of his contribution
to software quality improvement and
work with the Canadian and European space
agencies.
Chris
is the co-author of the book “ISO 9001 Registration for Small and
Medium Sized Software Enterprises” (McGill-Queens
Press, 1995) and published the Masters thesis “An
Analysis of the Differences in Software Project
Management Practices Between Organizations Registered
to ISO 9001 and Non-Registered Organizations” (Carleton
University, 1998). Chris is based in
Ottawa (Stittsville) Ontario. He is a
co-founder of Orion Canada. |
Mary Jo, Management System
Consultant |
Mary is an experienced project manager and
quality system leader with a particularly
strong background in manufacturing,
medical devices and service delivery.
She has worked within
organizations registered to ISO 9001, ISO
13485, ISO 17025, and TS16949 standards
where she has set up and managed quality
systems, and led the corrective &
preventive action, and audit functions.
Mary has led internal audits, supplier
audits, and represented organizations
through successful third-party audits for
the ISO 9001: 2015 requirements, ISO
13485:2016 requirements, and MDSAP. She is
also skilled in risk assessment, process
planning, project management, and
environmental system management.
Mary graduated from
Mechanical Engineering at Queen’s
University and is a member of the
Professional Engineers of Ontario. She is
a member of the American Society for
Quality. She is a certified quality
auditor (CQA), and has earned course
certificates for ISO 9001, ISO 13485:2016,
MDSAP, Quality system audits, and
Environmental system audits. Mary is a
certified ISO 9001 Lead Auditor (PECB LA).
She is based in Ottawa, Ontario.
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Veronica Marquez, Business Transformation
Consultant and Trainer |
Veronica Marquez is a multilingual supply chain and operational excellence consultant and trainer with more than 25 years of experience. She has worked in omnichannel distribution in a CPG organization, B2B distribution services, municipal operations, and with small and medium size organizations.
Veronica is known for her inclusive approach where she involves the entire organizational community in creating the vision of the future, exploring avenues for optimization, and co-developing the elements necessary to achieve her client’s business goals. She works on developing and aligning the strategy as well as implementing the tactical improvements and education required for success.
Veronica graduated from Concordia University with a BA in Political Science and HEC Montreal with a M.Sc in Operations Management. She is a certified Lean Six Sigma Black Belt from the American Society of Quality. She also volunteers in the leadership teams of ASQ Montreal and the Réseau des femmes d’affaires du Québec in Montérégie. In 2023, she was named one of the Top 50 Experts to follow in Operational Excellence by the PEX Network. She is based in the Montreal area.
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Mike de van der Schueren,
Management System Consultant |
Mike's expertise is built on more than 25
years of hands-on experience in quality
assurance and regulatory affairs in the
medical, nuclear, automotive and
manufacturing industries. He has designed,
implemented, managed, audited and improved
management systems that comply with the some
of the strictest medical device,
environmental, health & safety and nuclear
safety standards and regulations. From
troubleshooting problems on the production
floor, to defect prevention through SPC,
Mike always brings a process improvement
approach to achieve project success and
return on investment.
Mike earned his Bachelor of Science in
Mechanical Engineering from the University
of Waterloo. Mike is a certified auditor (CQA),
a medical device (ISO 13485) auditor, and an
Information Security Management System
(ISMS/ISO 27001) auditor. Mike is based in
Ottawa (Stittsville) Ontario. |
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Stephen
Davies, Management System Architect |
Stephen
Davies M.Sc., AIQA, CMQ-OE is a graduate of the
University of Wales College Cardiff (UWCC). He
gradated in 1991 with a B.Sc. (Hons) in Physics
with Music (Sound Engineering), and then went on
to graduate with an M.Sc. in Systems Engineering
from UWCC in 1992.
With well over a decade of industrial experience in Quality Assurance, Industrial
Engineering, Supply Chain Development, Manufacturing |
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Engineering,
Project Management and Strategy Development,
Stephen Davies brings a charismatic and dynamic
quality to his work. Trying to both inspire people
and to encourage conceptual thinking.
An
active member of both the American Society for
Quality (ASQ) and the Institute of Quality Assurance
(IQA) he is always at the forefront of new developments,
and is constantly aiming to research, publish
articles and to deliver papers to conferences.
In addition to his consultation role he also
lectures at the Sprott Business School at Carleton
University (Ottawa) and is a technology agent,
representing Silicon foundries and design groups
in North America. |
Peter Pringle, Software/Medical
Device Regulatory Consultant |
Peter Pringle leads Orion's European
consultancy. Peter is a UK-based consultant
and certified medical device auditor with
international hospital experience. He has
managed large scale medical product projects
(e.g., installations), implemented quality
systems, and overseen software development
projects. His medical background combined
with his software experience brings a unique
understanding of the quality systems,
configuration control and efficient medical
device compliance. |
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Peter is a certified and active medical
device auditor specializing in ISO 13485,
ISO 14971, ISO/IEC 62304 and FDA pre-audits.
Through his work with Notified Bodies, he
has reviewed numerous technical files. He
has prepared technical documentation
packages for regulatory submissions as well
as having professionally guided many
companies on efficiently preparing their
regulatory submissions. Peter has developed,
worked with and evaluated software
development methodologies, including
procedures and documentation.
From 1986 to
2000 he worked in the Radiotherapy
division of Philips Medical Systems
(purchased by Elekta of Sweden) whose main
products consist of a range of computer
controlled linear accelerators for the
treatment of cancer. After many years in
the medical industry working in hospital
environments, Peter became a consultant
(Accredited Business Link & MHRA) in 2000.
Since then, he has worked extensively in
Scandinavia, Germany, Italy, Russia, USA
and Great Britain, and for Orion clients
in North America and Europe.
Peter contributes a very personal view of
project processes, interpretation and
implementation to any forum, together with
a unique ability to focus a team on the
objectives and goals that are required by
the sponsor of the project. His leadership
skills create focus, vision and motivation
at all levels of a team.
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Doug Stowe P.Eng., Environmental &
OHSAS Consultant |
Doug has more than 20
years of chemical process engineering and
manufacturing engineering experience. He has
assisted numerous manufacturing companies
throughout the Ottawa region with their
environmental and health & safety compliance
and due diligence.
Doug began consulting
in 2002 and has worked on Orion Canada’s
largest environmental management and OHSAS
projects. He has overseen environmental
management programs (ISO 14001), safety
management systems (OHSAS 18001 / CSA
Z-1000) and performed Pre-Start Health and
Safety Reviews for new or modified equipment
installations. He has performed management
system audits as well as compliance audits
for integrated environmental and safety
management systems.
Doug is a licensed and
insured Professional Engineer (P.Eng.) in
Ontario and is also a Certified Hazardous
Materials Manager (CHMM) through the
Institute of Hazardous Materials Management
(IHMM) in the United States. This
American designation is also federally
endorsed by the CESB (Certified Engineering
Specialty Board) in the United States. Doug
is a lead auditor for ISO 14001 certified
through RABQSA.
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Daniel LeBlanc, Consultant, Auditor and
Professional Trainer |
With
more than 20 years in quality, Daniel is an
exceptional, senior Quality Management
professional whose experience covers all
sides of the quality industry. This includes
implementing and maintaining business
management systems from within world-class
organizations, carrying out third-party
audits for international registrars, and
providing consulting and training services
to client companies. Dan has worked as an
Air Weapons Director & Computer Systems
Analyst at the Department of National
Defence (DND Canada), a Manager of Quality
Assurance at Lockheed Martin Canada, Product
Assurance Manager at Com Dev Space Systems,
and a Quality Management Lead for the DND
Land Software Engineering Center through
ADGA Consulting Group. He has instructed
hundreds through professional training
courses on quality management standards and
auditing. He holds a degree in Mathematics
and is a certified Aerospace Industry
Experienced Auditor (AIEA) and Probitas QMS
Auditor. |
Sam
Weissfelner,
Aerospace & Security Auditor and Trainer |
Sam
is a quality professional with over 25 years
of experience in Systems and Software
Quality Assurance in the Aerospace,
Software, Telecommunications, and Military
fields. He is a consultant, trainer and
certified auditor to several standards,
including the latest version of the ISO
27001. Sam has worked with ISO 27001 since
its inception over 15 years ago and is also
familiar with BS 7799 – Information Security
Management, CAN/CSA Q830 – Canadian Code for
the Protection of Personal Information, and
the new GDPR requirements (released by the
European Economic Community on May 25th,
2018).
In addition to information security auditing
and consulting, Sam also works with the CMMI
assessment model, and he is a certified
Aerospace Industry Experienced Auditor
(AIEA), leading registration audits to the
latest AS9100D Aerospace standards.
Having conducted over
1000 Management System
audits in Canada, United States, Asia, South America,
Europe and the Middle East, Sam has helped a remarkable
number of organizations to improve their business
processes. He is an ASQ Certified Software Quality
Engineer (CSQE), Certified Quality Auditor (CQA),
and certified Lead Auditor (AS9100,
ISO 27001 and TL9000). He also develops
and conducts Quality and Information Security Management training programs,
and continues to support the development of high
reliability mission critical software systems. |
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